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NCT ID: NCT02951429 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension

Start date: December 31, 2016
Phase: Phase 2
Study type: Interventional

This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.

NCT ID: NCT02950883 Completed - Cystic Fibrosis Clinical Trials

Saline Hypertonic in Preschoolers + CT

SHIP-CT
Start date: March 24, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.

NCT ID: NCT02950831 Completed - Chronic Pain Clinical Trials

Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation

OASIS
Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess feasibility of using wearable sensors to capture objective assessments of patient's activity and sleep quality during the spinal cord stimulation (SCS) treatment continuum.

NCT ID: NCT02950051 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

GAIA
Start date: December 13, 2016
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions.

NCT ID: NCT02949232 Terminated - Schizophrenia Clinical Trials

Prednisolone Addition for Patients With Recent-onset Psychotic Disorder

Start date: July 2014
Phase: Phase 4
Study type: Interventional

Treatment with prednisolone can be used as a proof of concept to investigate the possibility of immune modulation as a treatment for schizophrenia. It is expected that daily treatment with prednisolone in addition to antipsychotic treatment reduces psychotic symptoms and improves cognition, as compared to placebo. The investigators propose to investigate the effects of administering the corticosteroid prednisolone versus placebo in addition to standard antipsychotic medication in patients with early stage schizophrenia or related disorders, hypothesizing that a decrease in the overall low-grade cerebral inflammation due to prednisolon treatment will be expressed as a decrease in overall symptom severity., Secondly, addition of prednisolone is hypothesised to slow down cognitive deterioration in recent-onset psychosis patients. Finally, the investigators aim to determine whether indirect immunological parameters of the hypothesised low grade inflammation status in schizophrenia are shifted due to the addition of prednisolone.

NCT ID: NCT02949154 Completed - Melanoma Clinical Trials

Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

Start date: November 2016
Phase:
Study type: Observational

A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.

NCT ID: NCT02948088 Completed - Giant Cell Tumors Clinical Trials

Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project

TOP
Start date: November 18, 2016
Phase:
Study type: Observational [Patient Registry]

TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT. This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.

NCT ID: NCT02947607 Completed - Clinical trials for Colorectal Adenoma and Carcinoma

Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma

Start date: July 2016
Phase:
Study type: Observational

The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.

NCT ID: NCT02947503 Recruiting - Insulin Resistance Clinical Trials

Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

POEM
Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

One approach to prevent the rising burden of diabetes is to address the issue of gestational diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM increases the risks of complications during pregnancy, at delivery and on the longer term, like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin added to diet as the standard care for GDM has disadvantages for mother (maintenance of hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia, hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer targeting the cause of GDM, may have essential benefits, as suggested by observational studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet and lifestyle improves clinically relevant pregnancy outcomes in mother and child during pregnancy, at delivery and on the longer term - up to 20 years after birth.

NCT ID: NCT02947347 Active, not recruiting - Follicular Lymphoma Clinical Trials

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Start date: January 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.